A Multi-Centric Single-Blind Randomized Placebo-Controlled Trial to Evaluate the Efficacy of the Individualized Homeopathic Intervention in Breast Fibroadenoma

Abstract

The primary objective of this study was to evaluate the efficacy of homeopathic medicines in the reduction or resolution of breast fibroadenoma (FA) through ultrasound (US) assessment in intervention and control groups. The secondary objective was to compare the efficacy of the homeopathic intervention in single and multiple fibroadenomas. A single-blind, randomized, placebo-controlled pilot study was conducted from January 2014 to June 2018 at 4 research centers with 6 months of follow-up. Females in the age group 18 to 35 years, with a confirmed diagnosis of breast fibroadenoma measuring between 1 cm and 5 cm, measured by the US, with only one fibroadenoma per quadrant were randomized to either homeopathic intervention (HI) or identical placebo (P) (n = 85) in each group. All the patients were enrolled in the study with due consent from them. The Ethical Committee, Central Council for Research in Homoeopathy (CCRH), New Delhi, India, approved the study. The trial was registered with the Clinical Trial Registry-India (CTRI) vide no. CTRI/2013/11/004144 [Registered on: 14/11/2013]. Out of the 85 cases enrolled in each group, the ITT analysis was done for n = 73 participants with a mean area of FA (3.11 ± 3.00) in HI and n = 77 participants with a mean area of FA (3.65 ± 3.29) in the P group at baseline. US assessment of 12 cases in the intervention group and 8 cases in the placebo group exceeded the study duration. Therefore, was analyzed as a sub-group and was not considered under ITT analysis. FA was the unit of analysis. At 6 months, complete resolution occurred in 2 participants in the intervention group and none in the placebo group. Although there is a significant difference between the intervention and the placebo groups at 3<sup>rd</sup> and 6<sup>th</sup> months, the within-group difference is insignificant. No significant difference is observed between and within the single and multiple FAs groups. Out of the 85 cases in the medicine group, 78 received a single remedy throughout the study in centesimal potencies. The frequently prescribed medicines were Pulsatilla, Silicea, Phosphorus, Sepia, and Calcarea Carbonica. IIndividualized homeopathy has significantly reduced FAs compared to the placebo group. However, the difference within the groups is not statistically significant. Future studies should be conducted based on adequate samples with long-term follow-up for resolution and recurrence if any.